Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 5:23 AM
Study NCT ID:
NCT04266158
Status:
TERMINATED
Last Update Posted:
2022-04-11
First Post:
2018-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
Functional Assistance Provided by Myoelectric Elbow-wrist- Hand Orthosis
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor stoppage of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAME
Brief Summary:
The primary study objective is to compare post-stroke upper extremity (UE) movement while wearing a brace called the MyoPro 2 Motion G versus UE movement while wearing a resting splint and no device in stroke survivors with moderate UE dysfunction. During the study, subjects will undergo general training in the operation of the EMG-controlled orthosis and the comparison orthosis, and then guided through a series of standard clinical outcome measures. These outcome measures will allow the researchers to directly compare the relative benefit of the MyoPro 2 Motion G with a resting hand splint and no device in reducing UE impairment and increasing UE dexterity and functional task performance.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: